June 20, 2005

Denver, CO, June 20, 2005 "“ Ramelteon, a novel investigational compound under review with the FDA for the treatment of insomnia, reduced the time it took to fall asleep and increased total sleep time in adults with chronic insomnia, according to results from a Phase 3 study presented this week at the 19th Annual Meeting of the Associated Professional Sleep Societies (APSS). Results of the study also showed no evidence of rebound insomnia, next-day impairments or withdrawal effects due to discontinuation.

According to the American Insomnia Association, more than 20 million Americans have complaints of chronic insomnia, a condition in which an individual cannot fall asleep, stay asleep and/or wake up feeling restored or refreshed for at least one month.

"Probably more than half of all Americans experience a sleep problem at some time in their lives, and it's a serious problem for many adults. People with insomnia often complain of impairments in intellectual abilities like attention, memory or concentration, impairments in their mood, feeling depressed or irritable or anxious, and impairment in their ability to function in the workplace, at home or even at school," said Gary Zammit, PhD, director of the Sleep Disorders Institute, St. Luke's-Roosevelt Hospital, New York, NY. "Despite this impact on productivity, many are hesitant to seek treatment."

These results were not confined to this single study. In other studies presented at the APSS meeting this week, ramelteon also helped older adults with chronic insomnia fall asleep faster and sleep longer. Additionally, ramelteon demonstrated no abuse potential or behavioral impairment.

Study Design:

A total of 405 adults with chronic insomnia (mean age, 39.3 years) were enrolled in this double-blind, placebo-controlled study. Participants received bedtime administration of ramelteon 8 mg or 16 mg, or placebo each night for 35 nights. For four nights during the course of the study, participants were monitored by polysomnography (PSG) in the sleep center; on all other nights during the study, participants slept at home.

Patients completed sleep questionnaires regarding their previous night's sleep, and also were evaluated for the presence of possible next-day memory, cognitive or motor impairment, rebound insomnia, and withdrawal effects after treatment discontinuation.

Results showed that during Week 1 of the study, participants in both the ramelteon 8 mg and 16 mg groups had shorter sleep latencies (sleep onset), longer total sleep times, and greater sleep efficiency compared with placebo. Analysis of task-performance data indicated no next-day memory, cognitive or motor impairment, and no withdrawal symptoms or rebound insomnia were observed following discontinuation of ramelteon treatment.

"In these trials, ramelteon, which possesses a unique mechanism of action, demonstrated an ability to help people fall asleep and sleep longer without next-day residual effects," said Stephen Sainati, MD, PhD, vice president of Clinical Research, Takeda, Lincolnshire, Ill.